PANTOPRAZOL CODRAMOL 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazole Codramol 40 mg Gastro-Resistant Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. - If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pantoprazole Codramol and what is it used for
2. What you need to know before you take Pantoprazole Codramol
3. How to take Pantoprazole Codramol
4. Possible side effects
5. Storage of Pantoprazole Codramol
6. Contents of the pack and other information

1. What is Pantoprazole Codramol and what is it used for

Pantoprazole Codramol is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

Pantoprazole Codramol is used for:

Adults and adolescents from 12 years:

• Reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat with your stomach) accompanied by acid reflux from the stomach.

Adults:

• Infection of a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacterium and thus reduce the likelihood of ulcer recurrence
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you take Pantoprazole Codramol

Do not take Pantoprazole Codramol

• If you are allergic (hypersensitive) to pantoprazole, or to any of the other components of Pantoprazole Codramol (see section 6)
• If you are allergic to medicines that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Be careful with Pantoprazole Codramol

• If you have serious liver problems. Tell your doctor if you have ever had liver problems. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazole. In case of an increase in liver enzymes, treatment should be discontinued.

• If you have decreased body reserves of vitamin B12 or risk factors for it and receive treatment with pantoprazole for a long period. Like all acid-reducing medicines, pantoprazole could reduce the absorption of vitamin B12.
• Tell your doctor if you are taking any medicine that contains atazanavir (for HIV infection treatment) at the same time as pantoprazole.

Warnings and precautions

Before taking this medicine, tell your doctor if:

• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Farmalider to reduce stomach acid.

If you suffer a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Pantoprazole Farmalider. Remember to mention any other symptoms you may notice, such as joint pain.

• It is planned that you will have a specific blood test (Chromogranin A)

• If you take pantoprazole for more than three months, you may suffer a decrease in magnesium levels in the blood. The symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have any of these symptoms, tell your doctor immediately. Additionally, low magnesium levels can produce a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

Tell your doctor immediatelyif you notice any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• blood in the vomit
• pale appearance and feeling of weakness (anemia)
• blood in your stools
• severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole can alleviate the symptoms of cancer and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than a year), your doctor may perform regular monitoring. You should tell your doctor about any new symptoms and/or unexpected events each time you visit your doctor.

Use of other medicines

Pantoprazole Codramol may influence the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazole Codramol may cause these and other medicines to not work properly.
• Warfarin and fenprocoumon, which affect blood coagulation. You may need additional controls.
• Atazanavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk. If you are pregnant, or think you may be pregnant, or if you are breastfeeding, you should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

You should not drive or use machines if you suffer from side effects such as dizziness or blurred vision.

3. How to take Pantoprazole Codramol

Follow exactly the administration instructions of Pantoprazole Codramol indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

When and how should you take Pantoprazole Codramol?

Take the tablets whole, without chewing or crushing, with a little water, 1 hour before a meal.

Unless your doctor has indicated otherwise, the usual dose is:

Adults and adolescents from 12 years:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.

Adults:

For the treatment of an infection with a bacterium calledHelicobacter pyloriin patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment)

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each to be taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the leaflets of the antibiotics.

The duration of treatment is usually one to two weeks.

For the treatment of stomach and duodenal ulcers:

The usual dose is one tablet per day. The dose may be doubled by your doctor.

Your doctor will indicate how long you should take this medicine. The duration of treatment for stomach ulcers is usually between 4 and 8 weeks. The duration of treatment for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion:

The recommended initial dose is two tablets per day.

Take the two tablets 1 hour before a meal. Later, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day.

If you are prescribed more than four tablets per day, you will be told exactly when you should finish the treatment.

Special patient groups:

1. If you have kidney problems or moderate or severe liver problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

1. If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (for this case, 20 mg pantoprazole tablets are available).

1. Children (under 12 years): the use of these tablets is not recommended in children under 12 years.

If you take more Pantoprazole Codramol than you should

Tell your doctor or pharmacist or call the Toxicology Information Service telephone 91 562 04 20, indicating the medicine and the amount ingested. There are no known symptoms of overdose.

If you forget to take Pantoprazole Codramol

Do not take a double dose to make up for forgotten doses. Take your next dose as usual.

If you stop taking Pantoprazole Codramol

Do not stop taking these tablets without consulting your doctor or pharmacist first.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pantoprazole Codramol can cause side effects, although not everybody gets them.

The frequency of the possible side effects described below is classified as follows:

• very common (affects more than 1 in 10 people)
• common (affects between 1 and 10 people in 100)
• uncommon (affects between 1 and 10 people in 1,000)
• rare (affects between 1 and 10 people in 10,000)
• very rare (affects less than 1 in 10,000 people)
• frequency not known (cannot be estimated from the available data).

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and profuse sweating.

• Severe skin reactions (frequency not known): blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and sensitivity to light.

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size with occasional pain when urinating, and lower back pain (severe kidney inflammation)

Other side effects are:

• Uncommon(affects between 1 and 10 people in 1,000)

headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances.

• Rare(affects between 1 and 10 people in 10,000)

vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

• Very rare(affects less than 1 in 10,000 people)

disorientation

• Frequency not known(cannot be estimated from the available data)

hallucination, confusion (especially in patients with a history of these symptoms), feeling of tingling, prickling, paresthesia (tingling), burning, or numbness, decreased sodium levels in the blood, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

If you are taking pantoprazole for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also produce a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like pantoprazole, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Side effects identified through blood tests:

• Uncommon(affects between 1 and 10 people in 1,000)

increased liver enzymes

• Rare(affects between 1 and 10 people in 10,000)

increased bilirubin; increased blood fat levels

• Very rare(affects less than 1 in 10,000 people)

reduction of platelet count that could produce bleeding or more bruising than usual; reduction of white blood cell count that could lead to more frequent infections.

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of Pantoprazole Codramol

Keep this medicine out of the sight and reach of children.

Do not use Pantoprazole Codramol after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Codramol

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of sodium sesquihydrate).

The other components (excipients) are:

Core:Mannitol (Pearitol 160C) (E-421), Microcrystalline cellulose (Avicel PH101), Microcrystalline cellulose (Avicel PH102), Pregelatinized corn starch (Starch 1500), Sodium starch glycolate (Explotab), Anhydrous sodium carbonate, Calcium stearate, Purified water (removed during the process).

Coating

Insulating coating:Hydroxypropyl methylcellulose, Propylene glycol, Titanium dioxide (E171), Yellow iron oxide (E172).

Enteric coating:Methacrylic acid and ethyl acrylate copolymer, Polysorbate 80, Sodium lauryl sulfate, Triethyl citrate, Purified water (removed during the process).

Appearance of the product and contents of the pack

Gastro-resistant tablet of light yellow color, elliptical and biconvex.

Packaging:

Available in blisters of 14 or 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

FARMALIDER S.A.

c/Aragoneses 15

28108 Alcobendas - Madrid

Spain

Manufacturer:

West Pharma – Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº11, Venda Nova. 2700 Amadora.

Lisbon (Portugal)

or

Atlantic Pharma Produções Farmacêuticas, S.A.

• da Tapada Grande, nº2

Abrumheira

2710-089 Sintra (Portugal)

Date of the last revision of this leaflet:October 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/